In-home use of a hybrid closed loop achieves time-in-range targets in preschoolers and school children: Results from a randomized, controlled, crossover trial.

AIM: To obtain additional information on the incremental differences between using a sensor-augmented pump (SAP) without automated insulin delivery (AID), using it with predictive low-glucose management (PLGM) or as hybrid closed loop (HCL), in preschool and school children. METHODS: We conducted a monocentric, randomized, controlled, two-phase crossover study in 38 children aged 2-6 and 7-14 years. The primary endpoint was the percentage of time in range (TIR) of 70-180 mg/dl. Other continuous glucose sensor metrics, HbA1c, patient-related outcomes (DISABKIDS questionnaire, Fear of Hypoglycaemia Survey) and safety events were also assessed. Results from 2 weeks of SAP, 8 weeks of PLGM and 8 weeks of HCL were compared using a paired t-test or Wilcoxon signed-rank test. RESULTS: Overall, we found a high rate of TIR target (>70%) achievement with HCL in preschool (88%) and school children (50%), with average times in Auto Mode of 93% and 87%, respectively. Preschool children achieved a mean TIR of 73% ± 6% (+8% vs. SAP, +6% vs. PLGM) and school children 69% ± 8% (+15% vs. SAP and + 14% vs. PLGM). Overall, HbA1c improved from 7.4% ± 0.9% to 6.9% ± 0.5% (P = .0002). Diabetes burden and worries and fear of hypoglycaemia remained at low levels, without significant changes versus PLGM. No events of severe hypoglycaemia or diabetic ketoacidosis occurred. CONCLUSIONS: Preschool children profit from AID at least as much as those aged 7 years and older. To ensure safe use and prescribing modalities, regulatory approval is also required for young children.

DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home.

AIMS: Previous DREAM studies demonstrated the safety and efficacy of the CE marked MD-Logic closed-loop system (DreaMed GlucoSitter) in different settings for overnight glycaemic control. The present study aimed to evaluate the system for day and night use for 60 hours during the weekend at home compared to sensor-augmented pump (SAP) therapy in participants with type 1 diabetes. METHODS: This was a prospective, multicentre, crossover, controlled study (clinicaltrials.gov NCT01238406). All participants were connected in randomized order for one weekend to SAP therapy or the MD-Logic System. In the intervention arm only, the amount of carbohydrate was entered into the bolus calculator; the rest of insulin delivery was automated and wireless via a tablet computer. The primary endpoint was percentage of glucose values between 70 and 180 mg/dL. RESULTS: The ITT population comprised 48 (19 males, 29 females) adolescents and adults experienced in sensor use: (median, [IQR]): age, 16.1years [13.2-18.5]; diabetes duration, 9.4 years [5.0-12.7]; pump use, 5.4 years [3.1-9.4]; HbA1c, 7.6% [7.0-8.1]. A significant increase in the percentage of time within target range (70-180 mg/dL) (66.6% vs 59.9%, P = 0.002) was observed with the closed-loop system vs control weekends with unchanged percentage of time below 70 mg/dL (2.3% vs 1.5%, P = 0.369). Mean weekend glucose level per participant was significantly lower (153 [142-175] vs 164 [150-186] mg/dL, P = 0.003). No safety signals were observed. CONCLUSIONS: The MD-Logic system was safe and associated with better glycaemic control than SAP therapy for day and night use. The absence of remote monitoring did not lead to safety signals in adapting basal rates nor in administration of automated bolus corrections.

Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice.

The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.

Longitudinal study of prosthesis use in veterans with upper limb amputation.

BACKGROUND: Little is known about the patterns of prosthesis use and satisfaction of those who cease use or begin to use upper limb prostheses. OBJECTIVES: Among a longitudinal sample of Veterans with upper limb amputation, (1) describe changes in prosthesis use over 1 year, (2) examine rates of receipt of new prostheses, and (3) compare prosthesis satisfaction in respondents who received a new prosthesis to those who did not. STUDY DESIGN: Longitudinal survey. METHODS: 808 Veterans who had participated in a baseline interview 1 year earlier were invited to participate in structured telephone interviews. RESULTS: A total of 562 persons with unilateral and 23 with bilateral amputation participated in the interviews (Response rate = 72.4% and 85.2%, respectively). Prosthesis use, frequency and intensity of use, and types of prostheses used were stable over 1 year. About 24% reported using a different primary terminal device type at follow-up than baseline. Prosthesis use was less frequent/intense at baseline among those who discontinued use compared with those who did not (P < 0.05), and less frequent/intense for those who started compared with those who continued using a prosthesis (P < 0.0001). Rates of prosthetic training were higher among those who received a different prosthesis type compared with those using the same type (P = 0.06). Satisfaction scores were higher (P < 0.01) for new prosthesis recipients, and lower at baseline for prosthesis abandoners compared with continued users (P = 0.03). CONCLUSION: Prosthesis abandonment appears to be predicated on dissatisfaction with the device, as well as less frequent/intense prosthesis use. These findings can be used to identify those at risk for prosthesis abandonment and improve their prosthesis experience.

Feminine identity and functional benefits are key factors in women's decision making about upper limb prostheses: a case series.

PURPOSE: Although the DEKA Arm promises new abilities, it is unclear if women with upper limb amputation are willing to avail themselves of this new technology. The study purpose was to understand key factors and tradeoffs that shape women's attitudes towards the DEKA Arm. METHODS: This case series includes three women with transradial amputation. Structured surveys and semi-guided interviews were administered after completion of in-laboratory training and a home trial of the DEKA Arm. A constant comparative method with a grounded theory approach was used to generate a model describing women's decision-making related to the DEKA Arm. Quantitative data on prosthetic satisfaction was used to triangulate findings. RESULTS: Factors that enhanced desirability of the DEKA Arm were improved functionality, increased abilities and the availability of someone to service the prosthesis. Factors that detracted from desirability of the device were its appearance, conspicuousness, lifestyle incompatibility, weight, need for service and difficulty of use. Each woman weighted these factors within the larger context of the capabilities of and satisfaction with her personal prostheses, her self-concept and lifestyle needs. Situational demands, particularly the desire to appear feminine and professional or need to perform certain activities, also altered the valuation of these priorities. CONCLUSION: Findings strongly suggest that advanced upper limb prosthetic technologies, like the DEKA Arm, will be better accepted by women if appropriately gendered in appearance and designed with women's priorities in mind. Implications for Rehabilitation Women should be able to derive the functional benefits of advances in upper limb technology without needing to compromise their feminine identity and lifestyle preferences. Advanced upper limb prosthetic technologies will be better accepted by women if they are appropriately gendered.